Glyceryl Eicosapentaenoate Products for Dry Skin

(COS-PBP-01 Trial)

Overseen By Samuel Fortin, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: SCF Pharma

Disqualifiers: Skin disease requiring treatment

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This exploratory study aims to verify the hydrating potential as well as the possible irritant effects of a 14-day hydrating treatment consisting of daily application of serum and cream to the skin of two dry targeted areas. Thirty-three (33) subjects will be enrolled in this study and will be divided into three different treatment groups of 11 subjects each. Apart from the formulation of the cream which varies between the three groups, the subjects will receive the same serum and adhere to the same study plan for fourteen days. Each subject's baseline condition before treatment will serve as a control for effects observed after treatment on targeted areas.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you have a skin disease that requires medication, you cannot participate.

What evidence supports the effectiveness of Glyceryl Eicosapentaenoate Products for Dry Skin?

Research shows that eicosapentaenoic acid (EPA), a component of Glyceryl Eicosapentaenoate, has anti-inflammatory properties that may help improve skin conditions by reducing inflammation. Additionally, polyunsaturated fatty acids like EPA can help maintain skin moisture and barrier function, which is beneficial for dry skin. ^{1 2 3 4 5}

Is Glyceryl Eicosapentaenoate safe for use on human skin?

There is no specific safety data available for Glyceryl Eicosapentaenoate in the provided research articles. ^{6 7 8 9 10}

What makes Glyceryl Eicosapentaenoate products unique for treating dry skin?

Glyceryl Eicosapentaenoate products are unique because they are derived from omega-3 fatty acids, which have anti-inflammatory properties that can help soothe irritated skin. Unlike other treatments, these products may offer additional benefits by competing with inflammatory compounds in the skin, potentially reducing irritation and improving skin barrier function. ^{2 6 7 11 12}

Research Team

Samuel Fortin, Ph.D

Principal Investigator

SCF Pharma

Eligibility Criteria

This trial is for individuals aged 18-65 with dry skin who can commit to the study's duration. They must be able to understand and follow instructions without intellectual impairments that affect consent or protocol adherence. Those with a diagnosed skin disease requiring medication cannot participate.

Inclusion Criteria

I can understand and follow the study's instructions.

I am between 18 and 65 years old.

I have dry skin.

Exclusion Criteria

I have a skin condition that needs medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants apply glyceryl eicosapentaenoate serum and cream daily to targeted skin areas for hydration and redness measurement

2 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Glyceryl Eicosapentaenoate Cream A
• Glyceryl Eicosapentaenoate Cream B
• Glyceryl Eicosapentaenoate Cream C
• Glyceryl Eicosapentaenoate serum

Trial Overview The study tests three different Glyceryl Eicosapentaenoate-based creams (A, B, C) and one serum for hydrating sensitive, dry skin over 14 days. Thirty-three participants will be divided into groups of eleven to receive one cream type each along with the same serum.

Participant Groups

Group I: Group C: Cream of formulation C Experimental Treatment 2 Interventions

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation C on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Group II: Group B: Cream of formulation B Experimental Treatment 2 Interventions

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation B on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Group III: Group A: Cream of formulation A Experimental Treatment 2 Interventions

Daily application of glyceryl Eicosapentaenoate serum and glyceryl Eicosapentaenoate cream of formulation A on both targeted skin area. The skin areas must be clean and dry. Subjects may proceed with additional product applications if needed. However, for each additional application, both targeted areas must be treated with the Serum and the cream. Subjects must proceed with at least one application of products each day for 14 consecutive days.

Who Is Running the Clinical Trial?

SCF Pharma

Lead Sponsor

Trials

7

Recruited

340+

Institut de recherche clinique du littoral (IRCL)

Collaborator

Trials

3

Recruited

100+

Findings from Research

In a study of 629 patients with clinically infected atopic dermatitis, the new lipid formulation of fusidic acid and betamethasone (Fucicort Lipid cream) showed a mean reduction in Total Severity Score of 82.9%, similar to the established Fucicort cream's 82.7%.

Both formulations demonstrated high efficacy in treating infections, with over 89% of patients achieving a successful bacteriological response, indicating that the lipid cream is a safe and effective alternative for short-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An efficient new formulation of fusidic acid and betamethasone 17-valerate (fucicort lipid cream) for treatment of clinically infected atopic dermatitis. Larsen, FS., Simonsen, L., Melgaard, A., et al.[2013]

In a 10-day trial with 22 patients suffering from moderate-to-severe atopic dermatitis, intravenous administration of n-3 fatty acids (fish oil) significantly improved disease severity compared to n-6 fatty acids (soybean oil), particularly noted on days 6 to 10.

The treatment with n-3 fatty acids led to increased levels of eicosapentaenoic acid (EPA) and changes in lipid mediators, suggesting a mechanism of action that may involve competition with arachidonic acid, although some patients experienced relapses after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled trial of n-3 versus n-6 fatty acid-based lipid infusion in atopic dermatitis. Mayser, P., Mayer, K., Mahloudjian, M., et al.[2017]

In a study involving 178 patients with mild-to-moderate psoriasis, a moisturizer containing linoleic acid and ceramide (LA-Cer) combined with mometasone furoate (MF) cream showed superior efficacy compared to MF alone, particularly in maintaining lower relapse rates at week 8.

The LA-Cer moisturizer not only improved the primary endpoint of psoriasis severity but also enhanced overall skin condition and quality of life, making it a promising long-term treatment option for managing psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a topical moisturizer containing linoleic acid and ceramide for mild-to-moderate psoriasis vulgaris: A multicenter randomized controlled trial. Li, X., Yang, Q., Zheng, J., et al.[2021]

A deficiency in linoleic acid and other polyunsaturated fatty acids can lead to skin disorders and increased water loss, highlighting the importance of these nutrients for skin health.

Supplementing diets with specific vegetable oils or fish oil can produce beneficial anti-inflammatory metabolites in the skin, suggesting a potential therapeutic approach for managing skin inflammatory disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The significance of polyunsaturated fatty acids in cutaneous biology. Ziboh, VA.[2019]

A deficiency in linoleic acid (LA) can lead to skin disorders and increased water loss, highlighting the importance of this polyunsaturated fatty acid for skin health.

The enzyme 15-lipoxygenase (15-LOX) plays a crucial role in metabolizing polyunsaturated fatty acids in the skin, producing compounds that may have anti-inflammatory effects by modulating key signaling pathways involved in cell growth and apoptosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological significance of essential fatty acids/prostanoids/lipoxygenase-derived monohydroxy fatty acids in the skin. Ziboh, VA., Cho, Y., Mani, I., et al.[2019]

Cod liver oil, known for its beneficial properties in wound healing and skin quality, can cause allergic reactions, as demonstrated in a case where a topical ointment with 40% cod liver oil induced a stronger allergic response than pure cod liver oil.

The study suggests that the difference in allergic reactivity may be due to the higher concentration of triacylglycerols (TAGs) in the ointment, which could enhance allergen penetration or act as sensitizers themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A matrix assisted laser desorption ionization time-of-flight mass spectrometry investigation to assess the composition of cod liver oil based products which displayed a different in vivo allergenic power. Calvano, CD., Zambonin, CG., Foti, C., et al.[2008]

In a study involving 21 healthy subjects, the sterol-enriched fraction from canola oil and hydrocortisone significantly reduced visible signs of irritation and transepidermal water loss (TEWL) on skin irritated by sodium lauryl sulfate (SLS), indicating their potential efficacy in treating skin irritation.

While most lipids tested did not show significant effects on normal skin, the findings suggest that certain lipids, particularly from canola oil, may help restore the skin barrier and alleviate irritation from external irritants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of topically applied lipids on surfactant-irritated skin. Lodén, M., Andersson, AC.[2013]

Aqueous Cream BP, commonly used for eczema, was found to reduce the thickness of the skin's outer layer (stratum corneum) by about 12% after 4 weeks of application, indicating potential harm to skin barrier function.

The cream also increased water loss from the skin, suggesting that it may worsen skin dryness rather than alleviate it, raising concerns about its use on already compromised skin in eczema patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Aqueous Cream BP on human stratum corneum in vivo. Tsang, M., Guy, RH.[2022]

17,18-Epoxyeicosatetraenoic acid (17,18-EpETE) effectively reduces contact hypersensitivity in both mice and cynomolgus macaques by inhibiting neutrophil mobility, suggesting its potential as a treatment for allergic inflammation.

The mechanism of action involves the activation of the G protein-coupled receptor GPR40, which is crucial for the anti-inflammatory effects of 17,18-EpETE, indicating that targeting this receptor could be a promising strategy for managing allergic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 17,18-epoxyeicosatetraenoic acid-G protein-coupled receptor 40 axis ameliorates contact hypersensitivity by inhibiting neutrophil mobility in mice and cynomolgus macaques. Nagatake, T., Shiogama, Y., Inoue, A., et al.[2019]

The study found that sodium lauryl sulfate (SLS)-free aqueous cream has a lower irritancy potential compared to SLS-containing aqueous cream, as evidenced by stable transepidermal water loss (TEWL) and Corneometer® readings over the study period.

In addition to being less irritating, the SLS-free cream maintained skin barrier integrity and hydration similarly to other tested moisturizers, suggesting it is a safer option for individuals with sensitive skin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Irritancy Potential of Sodium Lauryl Sulfate-free Aqueous Cream to Other Moisturizers: An Intraindividual Skin Occlusive Study. Mei-Hsia Chan, M., Tan, LS., Leow, YH., et al.[2020]

The study successfully developed methods for synthesizing stable hydroxy-epoxy derivatives of linoleic acid, which are crucial for understanding their role in forming the skin's permeability barrier.

These synthesized derivatives, particularly the 2,2-dimethyl analogs, are designed to resist esterification, allowing researchers to better study the bioactive properties of these lipids in their unesterified form.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stable analogs of 13‑hydroxy-9,10-trans-epoxy-(11E)-octadecenoate (13,9-HEL), an oxidized derivative of linoleic acid implicated in the epidermal skin barrier. Keyes, GS., Maiden, K., Ramsden, CE.[2022]

A clinical study showed that a nano-emulsion containing 10% phytosteryl/octyldodecyl lauroyl glutamate (POLG) significantly improved skin symptoms like dryness, itchiness, and scaling in patients with atopic dermatitis after 3 and 6 weeks of daily application.

The improvements in skin symptoms were linked to enhanced water content and skin smoothness, suggesting that POLG helps restore the skin's water-holding function, although it did not improve the overall barrier function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nano-Emulsion Containing Ceramide-like Lipo-Amino Acid Cholesteryl Derivatives Improves Skin Symptoms in Patients with Atopic Dermatitis by Ameliorating the Water-Holding Function. Takada, M., Ishikawa, Y., Numano, K., et al.[2023]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

An efficient new formulation of fusidic acid and betamethasone 17-valerate (fucicort lipid cream) for treatment of clinically infected atopic dermatitis. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

A double-blind, randomized, placebo-controlled trial of n-3 versus n-6 fatty acid-based lipid infusion in atopic dermatitis. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a topical moisturizer containing linoleic acid and ceramide for mild-to-moderate psoriasis vulgaris: A multicenter randomized controlled trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The significance of polyunsaturated fatty acids in cutaneous biology. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Biological significance of essential fatty acids/prostanoids/lipoxygenase-derived monohydroxy fatty acids in the skin. [2019]

6. England pubmed.ncbi.nlm.nih.gov

A matrix assisted laser desorption ionization time-of-flight mass spectrometry investigation to assess the composition of cod liver oil based products which displayed a different in vivo allergenic power. [2008]

7. England pubmed.ncbi.nlm.nih.gov

Effect of topically applied lipids on surfactant-irritated skin. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Effect of Aqueous Cream BP on human stratum corneum in vivo. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The 17,18-epoxyeicosatetraenoic acid-G protein-coupled receptor 40 axis ameliorates contact hypersensitivity by inhibiting neutrophil mobility in mice and cynomolgus macaques. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Comparison of Irritancy Potential of Sodium Lauryl Sulfate-free Aqueous Cream to Other Moisturizers: An Intraindividual Skin Occlusive Study. [2020]

11. Scotland pubmed.ncbi.nlm.nih.gov

Stable analogs of 13‑hydroxy-9,10-trans-epoxy-(11E)-octadecenoate (13,9-HEL), an oxidized derivative of linoleic acid implicated in the epidermal skin barrier. [2022]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Nano-Emulsion Containing Ceramide-like Lipo-Amino Acid Cholesteryl Derivatives Improves Skin Symptoms in Patients with Atopic Dermatitis by Ameliorating the Water-Holding Function. [2023]